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Zimmer Biomet, Inc. recalls ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guid
Recalled August 9, 2017 · FDA recall Z-2868-2017 · Zimmer Biomet
Hazard
Complaint of the head holder connector locking up mechanically when tightened. · FDA Class II
Units
20 units (16 US, 4 OUS)
Sold at
Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France
Description
Complaint of the head holder connector locking up mechanically when tightened.
Product
ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →